This invention relates to a film laminate structure for flexible containers. In particular, this invention relates to a multilayer high barrier laminate film structure for flexible containers capable of containing a product to be maintained and removed under sterile conditions.
Flexible containers are utilized in the medical industry for containing, inter alia, parenteral solutions, dialysis solutions, frozen drugs, nutrition products, respiratory therapy products, and plasma. Because these containers are utilized to contain fluids or solids that are introduced into a patient's body, it is necessary for the containers to be; essentially transparent; flexible; essentially free of extractables; and capable of maintaining the product contained therein under sterile conditions until the product is accessed or removed from the flexible container.
It is also important that the film used in constructing these containers is sufficiently strong so that the containers constructed from the film have sufficient strength. Moreover, if the laminate film is to be constructed into a commercially viable flexible container, it is necessary that the flexible film can be run on some type of commercial production machine. One such machine is a form, fill and seal packaging machine. A form, fill and seal packaging machine requires that the film be sealable on at least two sides. The side seals are typically effectuated by sealing the inside layer of the film to itself.
It may also be desirable to attach a fitment on the film structure to create a flexible container with a fitment. The fitment is typically heat sealed to the film. Accordingly, it may also be necessary that the film structure is heat sealable on its outside layer so that the fitment may be sealed thereto.
Because the film laminate is to be utilized for flexible containers that house a medical product that is to be introduced into a patient's body, it is necessary that the film structure does not contain chemicals that will be extracted by the medical product. This is an especially critical consideration when choosing an adhesive for bonding the laminate layers together. If a fitment is utilized and sealed to the outside layer of the film it is possible that there will be fluid communication between the product and the layers of the laminate. Thus, if the adhesive contains possible hazardous components that may be extractable the film may not include a fitment sealed to the outside well.
A further consideration in choosing the proper film for creating a flexible container is the product to be housed. In applications of the film to produce containers for products stored at room temperature, it is necessary that the film provides a container with sufficient barrier properties. Without a sufficient barrier, water vapor, oxygen, and other gases and vapors may permeate the film inactivating or degrading the product contained therein.
Thus, there is a need for a film laminate structure for creating a sterile flexible container that overcomes the disadvantages of the prior art.